A Randomized, Double Blind, Parallel Group Clinical Trial to Evaluate the Safety of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Treatment With Albendazole
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12,979
- 试验地点
- 2
- 主要终点
- Incidence and Severity of Treatment Emergent Adverse Events
研究概览
简要总结
The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of ivermectin, in individuals living in onchocerciasis endemic areas and in individuals living in onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity receiving concomitant albendazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent, or assent with parental or guardian written consent*
- •Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin (participants ≥12 years of age only).
- •Living in an onchocerciasis endemic area.
- •Age ≥4 years
- •All female participants of childbearing potential must commit to the use of a reliable method of birth control until 3 months after administration of investigational product (Month 3). * Expression of 'deliberate objection' will be the basis for assessing assent of children aged ≥ 4 to <6 years
排除标准
- •Pregnant or breast-feeding.
- •Any concurrent condition that, in the opinion of the Investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health.
- •Has received ivermectin or oral diethylcarbamazine (DEC) within 30 days of Baseline.
- •Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration.
- •Known or suspected allergy to ivermectin or moxidectin or their excipients and, in areas with high levels of LF co-endemicity, known or suspected allergy to albendazole and its excipients.
- •Self-reported planned or ongoing activities within the study period that would make it unlikely that the participant will be available for follow-up examinations.
- •Infection with Loa loa.
- •Height <90 cm.
研究组 & 干预措施
Moxidectin
In onchocerciasis endemic areas: Moxidectin 8 mg per oral on Day 0
干预措施: Moxidectin (Drug)
Ivermectin
In onchocerciasis endemic areas: Ivermectin treatment with approximately 150 µg/kg per oral determined based on height on Day 0
干预措施: Ivermectin (Drug)
Moxidectin with concomitant Albendazole
In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Moxidectin 8 mg per oral with concomitant albendazole 400 mg per oral on Day 0
干预措施: Moxidectin (Drug)
Moxidectin with concomitant Albendazole
In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Moxidectin 8 mg per oral with concomitant albendazole 400 mg per oral on Day 0
干预措施: Albendazole (Drug)
Ivermectin with concomitant Albendazole
In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Ivermectin treatment with approximately 150 microgram/kilogram (μg/kg) per oral determined based on height with concomitant albendazole 400 mg per oral on Day 0
干预措施: Ivermectin (Drug)
Ivermectin with concomitant Albendazole
In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Ivermectin treatment with approximately 150 microgram/kilogram (μg/kg) per oral determined based on height with concomitant albendazole 400 mg per oral on Day 0
干预措施: Albendazole (Drug)
结局指标
主要结局
Incidence and Severity of Treatment Emergent Adverse Events
时间窗: Up to 3 months
Participant incidence rates of treatment emergent adverse events following a single dose of moxidectin versus a single dose of ivermectin will be assessed separately by endemic area. Treatment emergent adverse events may also be pooled across both endemic areas (pooled monotherapy and combination therapies separately for moxidectin and ivermectin), provided a qualitative assessment shows they are similar enough to enable the interpretation of the pooled analysis.
次要结局
未报告次要终点